RVP

Drug Catalog - Product Detail

DESIPRAMINE HCL TAB 50 MG 100CT

NDC Mfr Size Str Form
23155-0580-01 AVET PHARMACEUTICALS 100 50MG TABLET
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PACKAGE FILES

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Generic Name
DESIPRAMINE HYDROCHLORIDE
Substance Name
DESIPRAMINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207433
Description
DESCRIPTION Desipramine hydrochloride, USP is an antidepressant drug of the tricyclic type, and is chemically: 5H-Dibenz [b,ƒ] azepine-5-propanamine,10,11-dihydro- N -methyl-, monohydrochloride. Each desipramine hydrochloride, USP tablet contains 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, or 150 mg of desipramine hydrochloride for oral administration. Inactive Ingredients The following inactive ingredients are contained in all dosage strengths: Hypromellose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate type A (potato), stearic acid, talc and titanium dioxide. Structure
How Supplied
HOW SUPPLIED Desipramine hydrochloride tablets, USP for oral administration are available as: 10 mg: white to off white, rounded square shape, biconvex, coated tablets with 'N6' debossed on one side and plain on other side. NDC 23155-578-01: Bottles of 100 25 mg: white to off white, round biconvex, coated tablets with 'I86' debossed on one side and plain on other side. NDC 23155-579-01: Bottles of 100 50 mg: white to off white, round biconvex, coated tablets with 'I82' debossed on one side and plain on other side. NDC 23155-580-01: Bottles of 100 75 mg: white to off white, round biconvex, coated tablets with 'I83' debossed on one side and plain on other side. NDC 23155-581-01: Bottles of 100 100 mg: white to off white, round biconvex, coated tablets with 'I84' debossed on one side and plain on other side. NDC 23155-582-01: Bottles of 100 150 mg: white to off white, round biconvex, coated tablets with 'I85' debossed on one side and plain on other side. NDC 23155-583-25: Bottles of 50 Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature]. Protect from excessive heat. Dispense in tight container with child-resistant closure. Dispense with Medication Guide available at:www.avetpharma.com/product Manufactured by: USV Private Limited Daman - 396210, India Manufactured for: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816 1.866.901.DRUG (3784) Revised: 06/2023 Dispense with Medication Guide available at:www.avetpharma.com/product logo
Indications & Usage
INDICATIONS AND USAGE Desipramine hydrochloride tablets, USP is indicated for the treatment of depression.
Dosage and Administration
DOSAGE AND ADMINISTRATION Not recommended for use in children ( see WARNINGS ). Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients compared to hospitalized patients, who are closely supervised. Dosage should be initiated at a low level and increased according to clinical response and any evidence of intolerance. Following remission, maintenance medication may be required for a period of time and should be at the lowest dose that will maintain remission. Usual Adult Dose The usual adult dose is 100 to 200 mg per day. In more severely ill patients, dosage may be further increased gradually to 300 mg/day if necessary. Dosages above 300 mg/day are not recommended. Dosage should be initiated at a lower level and increased according to tolerance and clinical response. Treatment of patients requiring as much as 300 mg should generally be initiated in hospitals, where regular visits by the physician, skilled nursing care, and frequent electrocardiograms (ECGs) are available. The best available evidence of impending toxicity from very high doses of desipramine hydrochloride is prolongation of the QRS or QT intervals on the ECG. Prolongation of the PR interval is also significant, but less closely correlated with plasma levels. Clinical symptoms of intolerance, especially drowsiness, dizziness, and postural hypotension, should also alert the physician to the need for reduction in dosage. Initial therapy may be administered in divided doses or a single daily dose. Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance . Adolescent and Geriatric Dose The usual adolescent and geriatric dose is 25 to 100 mg daily. Dosage should be initiated at a lower level and increased according to tolerance and clinical response to a usual maximum of 100 mg daily. In more severely ill patients, dosage may be further increased to 150 mg/day. Doses above 150 mg/day are not recommended in these age groups. Initial therapy may be administered in divided doses or a single daily dose. Maintenance therapy may be given on a once-daily schedule for patient convenience and compliance. Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders: At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with desipramine hydrochloride. Conversely, at least 14 days should be allowed after stopping desipramine hydrochloride before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS ). Use of desipramine hydrochloride With Other MAOI's, Such as Linezolid or Methylene Blue: Do not start desipramine hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue because there is increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS ). In some cases, a patient already receiving desipramine hydrochloride therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Desipramine hydrochloride should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with desipramine hydrochloride may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS ). The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with desipramine hydrochloride is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS ).